Especialista Edr Y Seguridad De Endpoints — Soc Hybrid

Kapres Technology; Málaga; Remote; EUR 65,000 - 95,000; Full time

Job summary

Cytel Inc. is seeking a Senior Statistical Programmer to leverage advanced SAS programming and CDISC SDTM/ADaM expertise to support or lead Phase I–IV clinical trials.

This role can be performed fully remotely, working with a global pharmaceutical client. You will design, implement and validate datasets, tables, listings and figures, perform data manipulation and analysis, and contribute to submission documents while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, or equivalent.
• At least 8 years of SAS programming in the Pharmaceutical & Biotech industry with a bachelor's, or 6+ years with a master's.
• Study lead experience preferred with ability to juggle multiple projects.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid CDISC SDTM/ADaM experience.
• QC/validation skills and ad-hoc reporting proficiency.
• Proficiency in Efficacy analysis and drug development lifecycle familiarity.
• Submissions experience with define.xml and related documents.
• Experience supporting immunology, respiratory, or oncology studies is a plus.
• Excellent analytical and troubleshooting abilities; capable of delivering high-quality output on tight timelines.
• Ability to work effectively in a globally dispersed team with cross-cultural partners.

Responsibilities

• Perform data manipulation, analysis and reporting of clinical trial data (safety and efficacy).
• Generate and validate SDTM and ADaM datasets/analysis files and TLFs.
• Production and QC/validation programming.
• Create and review submission documents and eCRTs.
• Communicate with internal cross-functional teams and clients on specifications and status.
• Lead projects when called upon and collaborate effectively with a globally dispersed team.

Skills

SAS programming

Data analysis

Efficacy analysis

CDISC SDTM/ADaM

Ad-hoc reporting

Study lead experience

QC/validation skills

Cross-functional communication

Troubleshooting

Leadership duties

Education

Bachelor's degree in Statistics/Computer Science/Mathematics

Master's degree (preferred) with more experience

Tools

SAS software

define.xml (submission documents)

Job description

Senior/Principal Statistical Programmer SAS + R (Remote)

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview

As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.

Our values

• We believe in applying scientific rigor to reveal the full promise inherent in data.
• We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
• We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
• We prize innovation and seek intelligent solutions using leading-edge technology.

How you will contribute

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties when called upon
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
• At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
• Study lead experience, preferably juggling multiple projects simultaneously preferred.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing the latest CDISC SDTM / ADaM standards.
• Strong QC / validation skills.
• Good ad-hoc reporting skills.
• Proficiency in Efficacy analysis.
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
• Submissions experience utilizing define.xml and other submission documents.
• Experience supporting immunology, respiratory or oncology studies would be a plus.
• Excellent analytical & troubleshooting skills.
• Ability to provide quality output and deliverables, in adherence with challenging timelines.
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

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Cytel Inc. is an Equal Employment / ... Applicant are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation